Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children

Recruiting now · Phase 4

Conditions studied: Pharmacokinetics of Tafenoquine

In brief

Plasmodium vivax is the most geographically widespread malaria species and the second largest contributor to symptomatic malaria worldwide. It accounts for half of all malaria cases outside Africa, with an estimated 14.3 million clinical vivax malaria cases reported annually, contributing to an annual cost of US$359 million. Children are most vulnerable to infection, with P. vivax prevalence peaking between 2 to 6 years of age. In Papua New Guinea (PNG), there are \>1.5 million suspected P. vivax cases annually, and while P. falciparum infections are the most prevalent, P. vivax transmission is the most intense in the world. P. vivax in PNG provides a unique epidemiological setting in which to assess innovative treatments in children. The complex biology of P. vivax represents a challenge for malaria control and chemotherapy, especially dormant liver-stage parasites (hypnozoites) which can reactivate (relapse) and cause disease at a time remote from the primary infection. Hypnozoite relapse is the primary cause of vivax malaria in endemic regions and is resistant to most antimalarial drugs. Identifying effective treatments for radical cure, the complete elimination of parasites (both blood- and liver-stage), is therefore a priority. The World Health Organization (WHO) recommends a 14-day radical cure regimen for uncomplicated vivax malaria; comprised of blood stage treatment (chloroquine or artemisinin combination therapy (ACT)) and 14 days of the 8-aminoquinoline drug primaquine (PQ; 0.25-0.5 mg/kg/day) for liver-stage cure. More recently, the 8-aminoquinoline tafenoquine has garnered interest as an alternative radical cure agent to primaquine. However, there is limited data on the pharmacokinetics, tolerability and radical cure efficacy of tafenoquine in children. The overall aim of the study is to characterise the pharmacokinetic profile of tafenoquine (and primary metabolite) in Papua New Guinean children.

Key facts

Study ID

NCT07052162

Run by

Curtin University

People needed

30

Starts

2025-10-20

Expected to finish

2026-03-01

Last updated by the study team

2026-03-18

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• have a normal glucose-6-phosphate-dehydrogenase (G6PD) activity (>70% enzyme activity) as confirmed by quantitative SD Biosensor
• are Rapid Diagnostic Test negative for malaria
• have not received treatment with any antimalarial in the previous 4-weeks
• have no signs or symptoms of significant morbidity
• have no history of hypersensitivity to primaquine
• are able to attend all scheduled follow-up visits

You may not qualify if…

• have G6PD activity <70%
• test positive for malaria by rapid diagnostic test
• have receive treatment with an antimalarial in the previous 4-weeks
• have signs or symptoms of significant morbidities
• have a history of primaquine related hypersensitivity
• cannot, or are not willing, to attend all scheduled follow-up visits

Where it is running

• Alexishafen Health Centre — Madang, Madang Province, Papua New Guinea (enrolling)

Full record on ClinicalTrials.gov

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